What RQMIS Inc. does

RQMIS Inc. (Regulatory/Quality Management Information Source) is a privately held professional services consulting firm founded in 1996 that provides integrated regulatory, clinical, quality management, postmarket surveillance, and cybersecurity advisory services to manufacturers of medical devices, pharmaceuticals, nutraceuticals, and cosmetics. The firm operates from three offices — Amesbury, MA (US headquarters), Witney, Oxfordshire (UK), and Barcelona, Spain (EU, hosted at the Barcelona Health Hub) — and positions itself as an embedded partner, frequently serving as the fully outsourced regulatory, clinical, and quality function for clients lacking internal teams. Service lines span the full product lifecycle: FDA 510(k)/De Novo/PMA submissions, EU MDR and UKCA marking, clinical study design and management (Phase II/III/IV), quality management system design and compliance (ISO 13485, FDA QSR 21 CFR 820, MDSAP), complaint handling and postmarket surveillance, and FDA administrative support including US Agent and EU/UK Authorized Representation. Notable proprietary assets include 109 Master Investigation Templates covering 15 device families and 330 failure categories, and customized electronic Trial Master File (e-TMF) reference models for medical device studies.

The firm's business model is project-based, quote-driven professional services revenue with no publicly disclosed pricing tiers; engagements are scoped per client. Customer acquisition relies on industry event presence (MEDICA, The Medtech Conference, MTEC Annual Membership Meeting, M2D2 events, 4YFN Barcelona), a 126+ article regulatory blog, published case studies, and partnership referrals through M-Corps/MTEC, M2D2, and the Barcelona and Madrid Health Hubs. The firm competes on the basis of former FDA reviewer talent, 30 years of accumulated regulatory relationships across FDA, EU Notified Bodies, UK MHRA, and Health Canada, and an integrated regulatory+clinical+quality offering that contrasts with competitors operating within single disciplines. Demonstrated outcomes include 510(k) clearance in under six months, combination product clearance in five months, FDA Warning Letter closure in six months, and QMS implementation in 30-45 days. Leadership is concentrated with founder/President Barry Sands; the firm reports 1-10 employees and has no disclosed external funding, M&A activity, or secondary ownership events.

Name

RQMIS Inc.

Legal name

Regulatory/Quality Management Information Source Incorporated

Website

https://rqmis.com

Company type

Private

Founded year

1996

Operating status

Operating

Headcount range

1–10 employees

Short description

RQMIS Inc. is a Boston-area regulatory, clinical, and quality management consulting firm serving medical device, pharmaceutical, nutraceutical, and cosmetic manufacturers across FDA, EU MDR, and UKCA pathways, with offices in the US, UK, and Spain.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

akta.pro primary industry

Regulatory Affairs & Submissions FSP (HLAGAOAD)

akta.pro secondary industries

Quality Assurance, GxP Compliance & Auditing FSP (HLAGAOAE), Training & Competency Programs for GxP Compliance (HLAGAKAM), Investigator & Site Training / GCP Support (HLAGACAF)

Keywords

• Medical device regulatory consulting
• FDA submission services
• Quality management systems
• Clinical study management
• Regulatory compliance consulting

Headquarters

HQ city

Amesbury

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Regulatory Consulting Services: Fees for regulatory strategy, submissions (510(k), De Novo, PMA, CE Mark, UKCA), FDA negotiations, Pre-Submission support, US Agent/Authorized Representative services, and Initial Importer services. Revenue is project-based and quote-driven.
2. Clinical Services: Fees for clinical study design and management, protocol development, IRB submissions, Trial Master File management, clinical monitoring, and post-market clinical follow-up (PMCF) studies. Revenue is project-based and quote-driven.
3. Quality Management Systems (QMS) Services: Fees for QMS design, implementation, ISO 13485 compliance, FDA QSR (21 CFR 820) alignment, CAPA development, internal audits, and audit readiness support. Revenue is project-based and quote-driven.
4. Postmarket Surveillance and Cybersecurity Services: Fees for complaint handling, MDR/Vigilance reporting, trend analysis, recall support, and cybersecurity testing/monitoring for medical devices. Revenue is project-based and quote-driven.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels12 records

Core offering

RQMIS is a professional services consulting firm that helps medical device, pharmaceutical, nutraceutical, and cosmetic manufacturers navigate FDA, EU MDR, UKCA, and Health Canada regulatory pathways. It delivers integrated regulatory strategy and submission services (510(k), De Novo, PMA, CE Mark), clinical study design and management, quality management system design and compliance (ISO 13485, MDSAP, 21 CFR 820), postmarket surveillance and complaint handling, and cybersecurity testing for software-based medical products. Engagements are project-based and quote-driven, with RQMIS frequently acting as a fully outsourced regulatory and quality department for clients lacking internal teams.

Product overview

RQMIS Inc. is a global regulatory consulting firm offering a unified portfolio of regulatory, clinical, and quality services rather than a software product. The core offerings span three principal areas: Regulatory Strategy and Submissions (covering FDA, EU MDR, UKCA pathways), Clinical Study Design and Management (protocol development, IRB submissions, Phase II/III/IV trials), and Quality Systems Design and Compliance (ISO 13485, FDA QSR/QMSR). Supporting services include Postmarket Surveillance, Cybersecurity Testing, FDA Administrative Support, EU/UK Authorized Representation, Initial Importer Services, and Customized Training Programs. The company operates as an embedded consulting partner, providing both strategy and execution support.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Services Comprehensive regulatory strategy and submission services covering FDA 510(k), De Novo, PMA, EU MDR, UKCA, Health Canada pathways, combination product clearance, and global market regulatory strategy for medical device, pharmaceutical, nutraceutical, and cosmetic manufacturers.
• Clinical Services Clinical study design, protocol development, investigational plan creation, IRB submissions, study management, and Phase II/III/IV clinical trial oversight including Trial Master File management, clinical monitoring, and post-market clinical follow-up (PMCF) studies.
• Quality Management Systems (QMS) for Medical Devices Design, implementation, and compliance of quality management systems aligned with ISO 13485, FDA QSR/QMSR (21 CFR 820), and MDSAP requirements, including design controls, risk management, CAPA, document control, internal audits, and audit readiness support.
• Postmarket Surveillance Service (PMSS) Post-market clinical follow-up (PMCF), complaint handling, MDR/Vigilance reporting, trend analysis, recall management, and postmarket surveillance system design for medical device manufacturers.
• Cybersecurity in Medical Devices Cybersecurity testing, penetration testing, postmarket surveillance planning, and compliance with FDA cybersecurity guidance requirements for software-based medical products and associated network and cloud-based platforms.
• FDA Administrative Support FDA correspondence management, facility registration, device listing, US Agent services for foreign manufacturers, and general regulatory administrative support for US market access.
• EU and UK Medical Device Authorized Representation EU Authorized Representative (EUAR) and UK Responsible Person (UKRP) services for non-EU and non-UK medical device manufacturers seeking market access in the European Union and United Kingdom.
• Initial Importer Service Designation and ongoing support services for initial importers under FDA regulations, supporting foreign manufacturers bringing products into the US market.
• Customized Training Programs Specialized training classes in quality and regulatory compliance, including Supplier/Internal Auditing, ISO 13485, Quality Systems Management, 21 CFR 820, and Risk Management ISO 14971, offered to manufacturers and eligible for reimbursement under Massachusetts WTFP.
• Cannabis for Medical Use in the U.S. Regulatory Consulting Regulatory consulting for cannabis-derived medical products including FDA compliance, state-level regulatory navigation, and pathway development for cannabis-based therapeutics in the US market.

Quantifiable outcome

• FDA 510(k) clearance achieved in under 6 months (including animal pre-clinical study design and execution)
• +5 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• M-Corps (Medical Technology Enterprise Consortium)coreStrategic or Co-development Partner · 17 July 2024RQMIS joined M-Corps, a component of the Medical Technology Enterprise Consortium (MTEC), to provide expert consulting services to MTEC members. M-Corps is an exclusive network of trusted subject matter experts and service providers dedicated to assisting MTEC members with complex business, technical, and regulatory challenges in medical product development.
• Commonwealth Corporation (WTFP)minorOthers · 1 July 2024RQMIS partnered with Commonwealth Corporation's Workforce Training Fund Program (WTFP) Express Program to offer specialized training classes in quality and regulatory compliance. Starting July 1, 2025, RQMIS offers 7 approved courses (Supplier/Internal Auditing, ISO 13485, Quality Systems Management, 21 CFR 820, Risk Management ISO 14971) eligible for up to 100% reimbursement for qualifying Massachusetts businesses.
• Twin Tech LabscoreTechnology or Integration · 26 June 2023RQMIS and Twin Tech Labs announced a partnership to bring cybersecurity testing and monitoring to the software-based medical products market and associated network and cloud-based platforms. Twin Tech Labs contributes decades of experience in IoT, machine learning, and cybersecurity, leveraging open-source components and frameworks to secure digital assets. RQMIS clients have already benefited from guidance and penetration testing by Twin Tech Labs on emergency triage devices and smartphone-based defibrillators.
• M2D2 (Medical Device Development Center, UMass Lowell)coreStrategic or Co-development PartnerRQMIS is a proud sponsor of M2D2 - a lifeline for Massachusetts' smaller medical device companies, offering inventors and executives affordable access to world-class researchers and resources at UMass Lowell and UMass Medical School campuses. RQMIS sponsors the M2D2 IMPACT accelerator program and participates in pitch-off events, providing regulatory expertise to early-stage medical device companies.
• Barcelona Health HubminorStrategic or Co-development PartnerRQMIS is a member of Barcelona Health Hub, an innovation hub based at the Recinte Modernista de Sant Pau in Barcelona. The partnership provides visibility within the European health innovation ecosystem and supports RQMIS's growing EU client base.
• Madrid Health HubminorStrategic or Co-development PartnerRQMIS is a member of Madrid Health Hub, providing visibility within the Spanish health innovation ecosystem and supporting the company's EU market presence.
• Medical Technology Enterprise Consortium (MTEC)coreStrategic or Co-development PartnerMTEC is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement with the U.S. Army Medical Research and Development Command (USAMRDC). MTEC's goal is to accelerate development of medical solutions for military personnel and civilians. RQMIS attends MTEC's Annual Membership Meeting and joined M-Corps to provide services to members.

Scale indicators12 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• RCRI: RCRI provides regulatory affairs, clinical research, and quality systems consulting for medical device and combination product companies, closely overlapping RQMIS's core service lines and customer base.
• MCRA: MCRA is a leading medical device-focused regulatory, clinical, and reimbursement consultancy serving the same FDA/EU MDR sponsor base with deeper headcount and orthopedics specialization.
• MDI Consultants: MDI Consultants delivers FDA regulatory strategy, 510(k) submissions, and QMS implementation for medical device manufacturers — a directly comparable boutique with similar delivery model.
• Greenleaf Health: Greenleaf Health is a Washington, DC-based FDA regulatory and policy consultancy serving pharma, biotech, and medical device companies — directly comparable for FDA-facing strategy work.
• The Weinberg Group: The Weinberg Group provides FDA regulatory, quality, and clinical consulting to medical device and combination product companies, mirroring RQMIS's outsourced-function positioning.
• StarFish Medical: StarFish Medical is a medical device design, development, and regulatory services firm serving start-ups through commercial-stage manufacturers — overlapping RQMIS on the medtech regulatory pathway.
• BioTeknica: BioTeknica is a medical device consulting firm offering QMS, regulatory submissions, and compliance services to ISO 13485 / FDA-regulated manufacturers — directly comparable in scope.

Broad incumbents

• NAMSA: NAMSA is the largest pure-play medical device CRO, offering regulatory, clinical, and laboratory services across the full device lifecycle — a much larger incumbent competing for the same engagements.
• ICON plc: ICON is a global CRO with extensive device and clinical-trial capabilities and the bench to absorb engagements that overflow boutique consultancies like RQMIS.

Emerging players

• Greenlight Guru (MasterControl): Greenlight Guru provides QMS software purpose-built for medical device companies; it competes for the QMS-implementation wallet share that RQMIS is paid to design and deploy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/rqmis_inc
• LinkedInlinkedin.com/company/rqmis-inc
• Facebookfacebook.com/rqmis

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RQMIS Inc.